Federal Register / Vol. 88, No. 230 / Friday, December 1, 2023 / Notices 83949 

1The notice of availability for the General Snus 

MRTPAs that received a modified risk granted order 

appeared in the Federal Register on August 27, 

2014 (79 FR 51183) and the docket containing 

notices and public comments, FDA–2014–N–1051, 

is accessible at: https://www.regulations.gov/. 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Dhanya John or Adrian Mixon, Office of 

Regulations, Center for Tobacco 

Products, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. G335, Silver Spring, 

MD 20993–0002, 1–877–287–1373, 

email: CTPRegulations@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 911 of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

387k) addresses the marketing and 

distribution of MRTPs. MRTPs are 

tobacco products that are sold or 

distributed for use to reduce harm or the 

risk of tobacco-related disease 

associated with commercially marketed 

tobacco products. Section 911(a) of the 

FD&C Act prohibits the introduction or 

delivery for introduction into interstate 

commerce of any MRTP unless an order 

issued by FDA pursuant to section 

911(g) of the FD&C Act is effective with 

respect to such product. 

Section 911(d) of the FD&C Act 

describes the information that must be 

included in a MRTPA, which must be 

filed and evaluated by FDA before an 

applicant can receive an order from 

FDA. FDA is required by section 911(e) 

of the FD&C Act to make a MRTPA 

available to the public (except for 

matters in the application that are trade 

secrets or otherwise confidential 

commercial information) and to request 

comments by interested persons on the 

information contained in the 

application and on the label, labeling, 

and advertising accompanying the 

application. The determination of 

whether an order is appropriate under 

section 911 of the FD&C Act is based on 

the scientific information submitted by 

the applicant as well as the scientific 

evidence and other information that is 

made available to the Agency, including 

through public comments. 

Section 911(g) of the FD&C Act 

describes the demonstrations applicants 

must make to obtain an order from FDA 

under either section 911(g)(1) or (g)(2). 

The applicant, Swedish Match U.S.A., 

Inc., is seeking a renewal of the order 

under section 911(g)(1) of the FD&C Act. 

FDA may issue an order under 

Section 911(g)(1) of the FD&C Act, if 

FDA has determined that the applicant 

has demonstrated that the proposed 

MRTP, as it is actually used by 

consumers, will: 

• Significantly reduce harm and the 

risk of tobacco-related disease to 

individual tobacco users; and 

• Benefit the health of the population 

as a whole taking into account both 

users of tobacco products and persons 

who do not currently use tobacco 

products. 

Section 911(g)(4) of the FD&C Act 

describes factors that FDA must take 

into account in evaluating whether a 

tobacco product benefits the health of 

individuals and the population as a 

whole. 

FDA is issuing this notice to inform 

the public that renewal MRTPAs 

submitted by Swedish Match U.S.A. Inc. 

for the following products (identified by 

FDA Submission Tracking Numbers 

(STN) (MR0000256.PD1— 

MR0000256.PD9)) have been filed and 

are being made available for public 

comment: 

• MR0000256.PD1: General Loose 

• MR0000256.PD2: General Dry Mint 

Portion Original Mini 

• MR0000256.PD3: General Portion 

Original Large 

• MR0000256.PD4: General Classic 

Blend Portion White Large-12 ct 

• MR0000256.PD5: General Mint 

Portion White Large 

• MR0000256.PD7: General Nordic 

Mint Portion White Large- 12 ct 

• MR0000256.PD8: General Portion 

White Large 

• MR0000256.PD9: General 

Wintergreen Portion White Large 

The applicant is seeking renewal of 

the authorization to market General 

Loose, General Dry Mint Portion 

Original Mini, General Portion Original 

Large, General Classic Blend Portion 

White Large—12ct, General Mint Portion 

White Large, General Nordic Mint 

Portion White Large—12ct, General 

Portion White Large, and General 

Wintergreen Portion White Large 

Smokeless Tobacco Products (category)/ 

Loose Snus and Portioned Snus 

(subcategories) as MRTPs under section 

911(g)(1) of the FD&C Act.1 These 

products previously received such 

authorization in October 2019, and the 

applicant is including information from 

the previous MRTPAs by crossreference. 

FDA will post the application 

documents, including any amendments, 

to its website for the MRTPAs (see 

section II) for public comment on a 

rolling basis as they are redacted in 

accordance with applicable laws. In this 

document, FDA is announcing the 

availability of the first batch of 

application documents for public 

comment. FDA intends to establish a 

closing date for the comment period that 

is both at least 180 days after the date 

of this notice and at least 30 days after 

the final documents from the 

application are made available for 

public comment. FDA will announce 

the closing date at least 30 days in 

advance. FDA believes that this 

comment period is appropriate given 

the volume and complexity of the 

applications being posted. 

FDA will notify the public about the 

availability of additional application 

documents and comment period closing 

date via the Agency’s web page for the 

MRTPAs (see section II) and by other 

means of public communication, such 

as by email to individuals who have 

signed up to receive email alerts. To 

receive email alerts, visit FDA’s email 

subscription service management 

website (https://www.fda.gov/about-fda/ 

contact-fda/get-email-updates), provide 

an email address, scroll down to the 

‘‘Tobacco’’ heading, select ‘‘Modified 

Risk Tobacco Product Application 

Update’’, and click ‘‘Submit’’. To 

encourage public participation 

consistent with section 911(e) of the 

FD&C Act, FDA is making the redacted 

MRTPAs that are the subject of this 

notice available electronically (see 

section II). 

II. Electronic Access 

Persons with access to the internet 

may obtain the document(s) at https:// 

www.fda.gov/tobacco-products/ 

advertising-and-promotion/swedishmatch-usa-inc-mrtp-applications. 

Dated: November 28, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–26498 Filed 11–30–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3007] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Registration of 

Human Drug Compounding 

Outsourcing Facilities Under the 

Federal Food, Drug, and Cosmetic Act 

and Associated Fees 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 


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83950 Federal Register / Vol. 88, No. 230 / Friday, December 1, 2023 / Notices 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by January 2, 

2024. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0776. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Registration of Human Drug 

Compounding Outsourcing Facilities 

Under Section 503B of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) and Associated Fees Under Section 

744K 

OMB Control Number 0910–0776— 

Extension 

This information collection helps to 

support implementation of section 503B 

of the FD&C Act (21 U.S.C. 353b) and 

the assessment and remission of user 

fees under section 744K of the FD&C 

Act (21 U.S.C. 379j–62). 

A. Registration 

Under section 503B of the FD&C Act 

a facility that compounds drugs may 

elect to register with FDA as an 

outsourcing facility. Upon electing to do 

so, outsourcing facilities must register 

annually between October 1 and 

December 31, providing information 

that includes its name, place of 

business, a unique facility identifier, 

and a point of contact’s email address 

and phone number. The outsourcing 

facility must also indicate: (1) whether 

it intends to compound, within the next 

calendar year, a drug that appears on 

our drug shortage list in effect under 

section 506E of the FD&C Act (21 U.S.C. 

356e) and (2) whether it compounds 

from bulk drug substances and, if so, 

whether it compounds sterile or 

nonsterile drugs from bulk drug 

substances. Registered outsourcing 

facilities must submit a drug product 

report upon initial registration under 

section 503B of the FD&C Act and twice 

each year in June and December for drug 

products produced during the previous 

6-month period. We require this data be 

submitted electronically, unless a 

waiver is granted, in structured product 

labeling (SPL) format. 

Drug products compounded in a 

registered outsourcing facility can 

qualify for exemptions from the FDAapproval requirements in section 505 of 

the FD&C Act (21 U.S.C. 355), the 

requirement to label products with 

adequate directions for use under 

section 502(f)(1) of the FD&C Act (21 

U.S.C. 352(f)(1)), and the requirements 

for drug supply chain security in section 

582 of the FD&C Act (21 U.S.C. 360eee– 

1) if the requirements in section 503B of 

the FD&C Act have been met. We 

provide general information and 

resources on our website at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

human-drug-compounding, including a 

list of currently registered outsourcing 

facilities as required under section 503B 

of the FD&C Act. 

B. Registration Fees 

Upon registration, and in accordance 

with sections 503B and 744K of the 

FD&C Act, facilities are assessed an 

establishment fee and receive an annual 

invoice from FDA with instructions for 

remitting payment. Until payment is 

made for each given fiscal year (FY), an 

establishment is not considered to be 

registered as an outsourcing facility. In 

accordance with section 744K of the 

FD&C Act, certain outsourcing facilities 

may qualify for a small business 

reduction in the amount of the annual 

establishment fee. To qualify for this 

reduction, an outsourcing facility must 

submit a written request to FDA 

certifying that the entity meets the 

requirements for the reduction. For each 

FY a firm seeks to qualify as a small 

business and receive the fee reduction, 

it must submit to FDA a written request 

by April 30 of the preceding FY. For 

example, an outsourcing facility must 

have submitted a written request for the 

small business reduction by April 30, 

2023, to qualify for a reduction in the 

FY 2024 annual establishment fee. 

Section 744K of the FD&C Act also 

requires an outsourcing facility to 

submit written requests for a small 

business reduction in a specified format: 

Form FDA 3908 entitled ‘‘Outsourcing 

Facilities for Human Drug 

Compounding: Small Business 

Establishment Fee Reduction Request.’’ 

The completed form should be 

submitted via email to 

CDERCollections@fda.hhs.gov. Form 

FDA 3908 is available from our website 

at: https://www.fda.gov/media/90740/ 

download. In response to the 

submission of a small business 

reduction request, FDA will send a 

notification letter of its decision and 

recommends that applicants retain the 

notification. 

C. Reinspection Fees 

In accordance with section 503B of 

the FD&C Act, outsourcing facilities are 

subject to inspection and, in accordance 

with section 744K of the FD&C Act, 

subject to reinspection fees. A 

reinspection fee will be incurred for 

each reinspection and is intended to 

reimburse FDA when a particular 

outsourcing facility requires 

reinspection because of noncompliance 

identified during a previous inspection. 

After a reinspection is conducted, FDA 

will send an invoice to the email 

address indicated in the facility’s 

registration file. The invoice contains 

instructions for remitting the 

reinspection fee. For further information 

on human drug compounding 

outsourcing facility fees, please visit our 

website at https://www.fda.gov/ 

industry/fda-user-fee-programs/humandrug-compounding-outsourcing-facilityfees. 

D. Dispute Resolution 

Agency regulations under § 10.75 (21 

CFR 10.75) provide for internal Agency 

review of decisions. Accordingly, an 

outsourcing facility may request 

reconsideration of an FDA decision 

related to the fee provisions of section 

744K of the FD&C Act. Requests for 

reconsideration should include the 

facility’s rationale for its position that 

FDA’s decision was in error and include 

any additional information that is 

relevant to the outsourcing facility’s 

assertion. The denial of a request for 

reconsideration may be appealed by 

submitting a written request to FDA, 

consistent with § 10.75. 

To assist respondents with the 

information collection provisions, we 

have developed Agency guidance 

documents. The guidance document 

entitled ‘‘Registration of Human Drug 

Compounding Outsourcing Facilities 

Under Section 503B of the FD&C Act 

(November 2014)’’ describes the process 

for electronic submission of 


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Federal Register / Vol. 88, No. 230 / Friday, December 1, 2023 / Notices 83951 

establishment registration information 

for outsourcing facilities and provides 

information on how to obtain a waiver 

from submitting registration information 

electronically. The guidance document 

entitled ‘‘Fees for Human Drug 

Compounding Outsourcing Facilities 

Under Sections 503B and 744K of the 

FD&C Act (November 2014)’’ (Fees for 

Human Drug Compounding Outsourcing 

Facilities guidance) describes the types 

and amounts of fees that outsourcing 

facilities must pay, the adjustments to 

fees required by law, how outsourcing 

facilities can submit payment to FDA, 

the consequences of outsourcing 

facilities’ failure to pay fees, and how an 

outsourcing facility can qualify as a 

small business to obtain a reduction in 

fees. The guidance documents were 

issued consistent with our good 

guidance practice regulations (21 CFR 

10.115), which provide for public 

comment at any time, and are available 

on our website at https://www.fda.gov/ 

media/87570/download and https://

www.fda.gov/media/136683/download, 

respectively. 

All requests for dispute resolution 

should be sent via email to the Division 

of User Fee Management and Budget 

Formulation at CDERCollections@

fda.hhs.gov. If an outsourcing facility 

does not have email access, it can mail 

a request to FDA via the carrier of its 

choice. For the most updated physical 

mailing address, visit this website: 

https://www.fda.gov/aboutfda/ 

centersoffices/officeofmedical

productsandtobacco/cder/ 

ucm382846.htm. 

In the Federal Register of August 15, 

2023 (88 FR 55464), we published a 60- 

day notice soliciting comment on the 

proposed collection of information. No 

comments were received. 

We estimate the burden of the 

information collection as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity; 21 CFR section; guidance or associated FDA 

form 

Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

Electronic Submission of Registration Information 

Using the SPL Format; 207.61; Section III. of the 

‘‘eDRLS’’ 2 guidance.

79 1 79 4.5 ....................... 355 

Waiver Request from Electronic Submission of Registration Information; 207.65; Section VI. of the 

‘‘eDRLS’’ 2 guidance.

1 1 1 1 .......................... 1 

Remission of Annual Establishment Fee from FDA Invoice; Section E.1. of the Fees for Human Drug 

Compounding Outsourcing Facilities guidance.

76 1 76 0.5 (30 minutes) .. 38 

Request for Small Business Reduction (Form FDA 

3908).

18 1 18 25 ........................ 450 

Reinspection Fees; Section C. of the Fees for Human 

Drug Compounding Outsourcing Facilities guidance.

12 1 12 0.5 (30 minutes) .. 6 

Reconsideration Requests; Section V.B.1. of the Fees 

for Human Drug Compounding Outsourcing Facilities 

guidance.

1 1 1 1 .......................... 1 

Appeal of Reconsideration Denials; Section V.B.2. of 

the Fees for Human Drug Compounding Outsourcing Facilities guidance.

1 1 1 1 .......................... 1 

Total ........................................................................ ........................ ........................ 188 .............................. 852 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2 ‘‘Providing Regulatory Submissions in Electronic Format—Drug Establishment Registration and Drug Listing’’ (May 2009; available at: https://

www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-drug-establishment-registration-and-drug-listing). 

We estimate 79 respondents annually 

will submit outsourcing facility 

registrations using the SPL format as 

specified in Agency guidance and 

assume each registration will require 4.5 

hours to prepare and complete. We 

expect no more than one waiver request 

from the electronic submission 

requirement annually and assume each 

waiver request will require 1 hour to 

prepare and submit. We estimate each of 

the 76 registrants will remit annual 

establishment fees and assume this task 

requires 30 minutes per respondent. We 

estimate that 18 of those respondents 

will request a small business reduction 

in the amount of the annual 

establishment fee using Form FDA 3908. 

We estimate 12 outsourcing facilities 

annually will remit reinspection fees 

and assume this will require 30 

minutes. We also estimate that we will 

receive one request for reconsideration 

and one appeal of a denial of a request 

for reconsideration and assume 1 hour 

per respondent for this activity. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden 

per recordkeeping Total hours 

Retention of Small Business Designation Notification 

Letter.

18 1 18 0.5 (30 minutes) .. 9 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 


lotter on DSK11XQN23PROD with NOTICES1
83952 Federal Register / Vol. 88, No. 230 / Friday, December 1, 2023 / Notices 

We estimate that annually 18 

outsourcing facilities will maintain a 

copy of their small business designation 

letter and that maintaining each record 

will require 30 minutes. These estimates 

reflect a slight increase in the number of 

annual registrations, but a decrease in 

reinspection fee submissions. 

Dated: November 24, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–26445 Filed 11–30–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0955–0018] 

Agency Information Collection 

Request; 60-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before January 30, 2024. 

ADDRESSES: Submit your comments to 

Sherrette.Funn@hhs.gov or by calling 

(202) 264–0041 and PRA@HHS.GOV. 

FOR FURTHER INFORMATION CONTACT: 

When submitting comments or 

requesting information, please include 

the document identifier 0955–0018–60D 

and project title for reference, to 

Sherrette A. Funn, email: 

Sherrette.Funn@hhs.gov, PRA@

HHS.GOV or call (202) 264–0041 the 

Reports Clearance Officer. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: 21st Century 

Cures Act: Interoperability, Information 

Blocking, and the ONC Health IT 

Certification Program. 

Type of Collection: Extension. 

OMB No.: 0955–0018. 

Abstract: The Department of Health 

and Human Services, Office of the 

Secretary, Office of the National 

Coordinator for Health IT Office of 

Policy, is requesting an approval by 

OMB on an extension request which 

pertains to a records and information 

retention requirement found at 45 CFR 

170.402(b)(1). The purpose and use of 

this records and information retention 

requirement is to verify, as necessary, 

health IT developer compliance with 

the ONC Health IT Certification Program 

(Program) requirements, including 

certification criteria and Conditions and 

Maintenance of Certification. 

Specifically, a health IT developer must, 

for a period of 10 years beginning from 

the date each of a developer’s health IT 

is first certified under the Program, 

retain all records and information 

necessary that demonstrate initial and 

ongoing compliance with the 

requirements of the Program. 

ANNUALIZED BURDEN HOUR TABLE

Respondents 

(if necessary) 

Number of 

respondents 

Number of 

responses per 

respondents 

Average 

burden per 

response 

Total 

burden 

hours 

Health IT Developers ....................................................................................... 435 1 104 45,240 

Total .......................................................................................................... 435 ........................ ........................ 45,240 

Sherrette A. Funn, 

Paperwork Reduction Act Reports Clearance 

Officer, Office of the Secretary. 

[FR Doc. 2023–26477 Filed 11–30–23; 8:45 am] 

BILLING CODE 4150–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 30-Day 

Comment Request; Assurance 

(Interinstitutional, Foreign, and 

Domestic) and Annual Report Office of 

the Director (OD) 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, the 

National Institutes of Health (NIH) has 

submitted to the Office of Management 

and Budget (OMB) a request for review 

and approval of the information 

collection listed below. 

DATES: Comments regarding this 

information collection are best assured 

of having their full effect if received 

within 30 days of the date of this 

publication. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: To 

submit comments in writing or request 

more information on the proposed 

collection, contact: Jane J. Na, Director, 

Division of Assurances, Office of 

Laboratory Animal Welfare, NIH, call 

(301) 496–7163 or email your request to 

olawdoa@mail.nih.gov. Formal requests 

for information collection forms must be 

requested via email to olawdoa@

mail.nih.gov. 

SUPPLEMENTARY INFORMATION: This 

proposed information collection was 

previously published in the Federal 

Register on December 15, 2022, Vol. 87, 

No. 240 page 76631–76632 (87 FR 

76631) and allowed 60 days for public 

comment. No public comments were 

received. The purpose of this notice is 

to allow an additional 30 days for public 

comment. 

The Office of the Director (OD), 

National Institutes of Health (NIH), may 

not conduct or sponsor, and the 

respondent is not required to respond 

to, an information collection that has 

been extended, revised, or implemented 

on or after October 1, 1995, unless it 

displays a currently valid Office of 

Management and Budget (OMB) control 

number. 


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